Sr Manager, QA

Work Schedule

Environmental Conditions

Job Description

The Site Quality Head is responsible for leading QA Leaders in Clinical Packaging to assure compliance with cGMP’s, company procedures and customer requirements. Responsibilities include working with regulatory agencies to ensure compliance, leading quality systems, and driving process improvement initiatives. Interaction with a key customer is also required to assure them of the site’s commitment to quality. It also serves to facilitate their understanding of our quality system and ensures we are partnering with them to align with any specific quality needs.

This role will report to the Senior Quality Director, North America with a matrix to the site General Manager. This Quality Leader will champion and pursue world class quality, promote a GXP culture and assure regulatory compliance.

Key Responsibilities:

The Site Quality Head will be responsible for the following:

• Establishing and leading current and long-range objectives and activities in accordance with policies, goals and objectives established by the Senior Quality Director, Americas and CTD Leadership team.
• Providing leadership, enablement and direction to the Quality team to ensure that the quality system is fulfilling the regulatory and business needs for the site.
• To work via business development and Project Management to ensure that the Quality function is engaged with customer to ensure that Quality is a service differentiation for FCS globally.
• Ensuring PPI (Practical Process Improvement) is adopted across the quality organization for continual review of the Quality System and the creation of new or revised procedures to effect improvements, reduce costs, and enhance efficiency.
• Developing and maintaining a robust site quality plan and ensuring a robust audit mechanism is established internally.
• Supervising Quality performance and effectively partnering with business to resolve quality issues
• Staffing Quality department to support the business objectives; develops goals and objectives for department members.
• Emphasizing the critical need for timely delivery through the lens of full compliance; supporting team to overcome barriers and driving this focus across functions.
• Serve as a Role Model Leader demonstrating strong communication and interactions with colleagues, promoting quality and safety, and developing talent within the organization

Qualifications:

• BA/BS is preferred in a pharmaceutical/health related field. Advanced degree such as MBA or Masters a plus.
• Significant managerial QA / regulatory compliance experience in the pharmaceutical, chemical, medical device or biotech industry.
• Significant managerial experience in regulatory field as stated above
• Knowledge of clinical trial supply and commercial packaging
• Operational and/or Engineering experience (nice to have)
• Teamwork especially in a matrix management organization. Ability to influence across functions across Fisher sites and across companies to achieve objectives.
• Good communication skills both internally and externally. Ability to understand the clients’ requirements and to be able to devise and articulate the most appropriate solutions.
• Strong customer management skills. Must be highly flexible and adaptable while maintaining strategic direction. Needs to become comfortable with ambiguity.
• Ability to lead, motivate and influence others. Highly influential at team building, coaching and mentoring with a passion for encouraging others at all levels of the organization.
• Experience in developing others through personalized development plans with a track record of developing future leaders.
• Embodies our Thermo Fisher values of Integrity, Involvement, Intensity and Innovation.
• Ability to travel regionally as business requires (10%).